Improving PTSD treatment for veterans with serious mental illness
PTSD Treatment for Veterans With Serious Mental Illness to Improve Functional Outcomes
NA · VA Office of Research and Development · NCT05674617
This study is testing if a new therapy called Written Exposure Therapy can help veterans with PTSD and serious mental illness feel better, especially focusing on the experiences of Black, Indigenous, and other people of color.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05674617 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and acceptability of Written Exposure Therapy (WET) for veterans suffering from PTSD and serious mental illness (SMI). It addresses the significant gaps in research regarding effective PTSD treatments for this population, particularly among Black, Indigenous, and other people of color (BIPOC). The study will involve administering culturally responsive assessments and conducting qualitative interviews to gather insights on participants' experiences. A small randomized controlled trial will follow to assess the implementation of WET and its impact on clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans diagnosed with PTSD and serious mental illness who are enrolled in outpatient mental health services.
Not a fit: Patients currently engaged in trauma-focused evidence-based practices for PTSD or with moderate-to-severe substance use issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mental health outcomes for veterans with PTSD and serious mental illness.
How similar studies have performed: While there is limited research specifically on WET for veterans with SMI, other studies have shown promise in using culturally responsive approaches for PTSD treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * enrolled in outpatient mental health services within the VAMHCS (including general outpatient Mental Health Clinic (MHC), Psychosocial Rehabilitation and Recovery Centers (PRRCs), Mental Health Intensive Case Management (MHICM), and PTSD Clinical Teams (PCTs)) * diagnosis of PTSD as confirmed by assessment with the Clinician-administered PTSD Scale for DSM-5 (CAPS-5) past month version * SMI diagnosis as defined by VHA Directive 1160 (i.e., psychotic spectrum or bipolar disorders) as confirmed by the medical record * regular telephone access Exclusion Criteria: * are engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care * already engaged in trauma-focused EBP for PTSD (e.g., WET, CPT, PE, or EMDR) or completed an EBP for PTSD within the past 6 months
Where this trial is running
Baltimore, Maryland
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Mary K Howell, PhD — Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- Study coordinator: Mary K Howell, PhD
- Email: Mary.Howell@va.gov
- Phone: (410) 605-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stress Disorders, Post-Traumatic, Mental Disorders, Culturally responsive assessment